Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain
Sponsor
Kyunghee University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01491321
Collaborator
Kyung Hee University Hospital at Gangdong (Other)
54
1
2
11
4.9
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain
Study Start Date
:
Apr 1, 2011
Anticipated Primary Completion Date
:
Mar 1, 2012
Anticipated Study Completion Date
:
Mar 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bee Venom Acupuncture & Loxoprofen
|
Procedure: Bee Venom Acupuncture Therapy
Bee Venom 1:20,000 under BVA Increment Protocol
Increment Protocol as
1st week : SC 0.2cc/day, 2days/week
2nd week : SC 0.4cc/day, 2days/week
3rd week : SC 0.8cc/day, 2days/week
Other Names:
Drug: Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other Names:
|
| Placebo Comparator: Sham Bee Venom Acupuncture & Loxoprofen
|
Drug: Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other Names:
Procedure: Placebo
Normal Saline (0.9% NaCl) under NS Increment Protocol
Increment Protocol as
1st week : SC 0.2cc/day, 2days/week
2nd week : SC 0.4cc/day, 2days/week
3rd week : SC 0.8cc/day, 2days/week
|
Outcome Measures
Primary Outcome Measures
- Visual Analogue Scale for bothersomeness [Changes from baseline in VAS at 1 month]
Secondary Outcome Measures
- Visual Analogue Scale for pain intensity [Changes from baseline in VAS at 1 month]
- Disability scores on Oswestry Disability Index [Changes from baseline in ODI at 1 month]
- Quality of Life scores on EQ-5D [Changes from baseline in EQ-5D at 1 month]
- Depression scores on Beck Depression Inventory [Changes from baseline in BDI at 1 month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
nonspecific, chronic low back pain over 3 months
-
Must have LBP of more than VAS 4
Exclusion Criteria:
-
cancer, vertebral fracture, spinal infection, inflammatory spondylitis
-
spinal operation
-
radicular pain
-
other musculoskeletal pain
-
physicological or mental disorders
-
allergic history to BV therapy or insect bite
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spine Center, Kyung Hee University Hospital at Gangdong | Seoul | Korea, Republic of | 134-727 |
Sponsors and Collaborators
- Kyunghee University Medical Center
- Kyung Hee University Hospital at Gangdong
Investigators
- Principal Investigator: Jun-Hwan Lee, Spine Center, Kyung Hee University Hospital at Gangdong
- Study Director: Byung-Kwan Seo, Spine Center, Kyung Hee University Hospital at Gangdong
- Study Director: Dae-Jin Cho, Spine Center, Kyung Hee University Hospital at Gangdong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
JLee,
Clinical Assistant Professor,
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01491321
Other Study ID Numbers:
- KHNMC-OH-IRB 2011-006
First Posted:
Dec 14, 2011
Last Update Posted:
Mar 21, 2012
Last Verified:
Mar 1, 2012
Keywords provided by JLee,
Clinical Assistant Professor,
Kyunghee University Medical Center
Additional relevant MeSH terms: